839492

The American National Red Cross - Southern Region — FEI 1073000

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Douglasville, GA (United States)

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
139321 CFR 211.103Yield calculations not verified by 2nd person
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs